Senior Specialist, QA for QC

Job Description

The Quality team have a great opportunity for a Senior Specialist, QA for QC at our Dundalk facility.

The QA Senior Specialist works as directed by the QA Lead according to Quality Management System, cGMP and regulatory requirements. This role will ensure that objectives are effectively achieved, consistent with quality requirements to ensure compliance, safety and reliable supply to our customers.

Bring energy, knowledge, innovation to carry out the following:

• Provide Quality oversight to quality control activities as part of facility start up and to ensure compliance with company policies, procedures and regulatory expectations.
• Provide Quality oversight to quality control GMP laboratory activities.
• Quality Operations System or Topic ownership, demonstrates independent and full ownership and decision making for said topic as required.
• Provide QA oversight and support of quality control continuous improvement projects. Use of Quality Risk Management and Operational Excellence to promote continuous improvement and ownership of Quality related improvement projects.
• Act as delegate for QA Lead regarding decision making and delegation to quality team.
• Perform Quality review and approval of analytical test methods, analytical protocols and analytical reports.
• Perform Quality review and approval of material specification and approval of laboratory and out of specification investigations.
• Provide Quality oversight of laboratory and out of specification investigations.
• Review and approval of analytical trend reports.
• Provide support for management of analytical equipment.
• Support quality control for area audits and participate and lead GEMBA floor inspections. Provide support and participate in corporate and regulatory inspections.
• Input to site quality control and quality assurance Standard Operating Procedures (SOPs) and Work Instructions (WI).
• Support sustaining activities such as Deviation and Change Management.
• Mentoring of new hires and delivery of required training.

What skills you will need:

In order to excel in this role, you will more than likely have:

• Bachelor’s degree (or higher) in Chemistry, Biology, or relevant discipline, the successful candidate will also ideally have a proven track record in delivering excellence.
• Microbiological Analytical and Technical experience in analytical techniques.
• Experience working in regulated environment with exposure in the Regulations & guidance’s – GMP, CGMP, GAMP, 21 CFR Part 11
• Experience in review of analytical data, method validation/qualification/technology transfer desired.
• Experience working with global pharmacopoeias.
• A great communicator, decisive decision maker and proven ability to deliver excellence.
• Strong contemporary knowledge of relevant cGMPs, regulations and current industry trends.

We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.

As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.

Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.

We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.

Please feel free to speak to us about what flexibility means to you during your application.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs, please apply today.

Current Employees apply HERE

Current Contingent Workers apply HERE

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. P